FDA recall Z-3023-2020
Philips North America, LLC · Class II · device
Product
ProxiDiagnost N90
Reason for recall
Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.
Distribution
United States
Key facts
- Status
- Terminated
- Initiation date
- 2019-11-20
- Report date
- 2020-10-07
- Termination date
- 2024-04-04
- Voluntary/Mandated
- FDA Mandated
- Location
- Andover, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3023-2020